End of Study Activities
End of study for a subject is determined as either completion of the final study visit at the end of the post-procedure phase as per protocol, or completion of an earlier visit due to a subject’s early voluntary withdrawal or early investigator termination.
END OF STUDY FORM
The END OF STUDY case report form will be completed at the time of the subject’s final study visit. The END OF STUDY form will document if the subject completed the entire study as per protocol, or the date and reason for early termination.
EARLY STUDY TERMINATION FORM
The EARLY STUDY TERMINATION case report form will be completed if the subject’s final study visit is the not the study final visit. The EARLY STUDY TERMINATION form will document the date of early termination, the last study visit/action completed, whether the early termination was initiated by the subject or the Principal Investigator, and the reason for the early termination.
- Exit Physical Examination, as per the study qualification evaluation.
- Exit Neurological Examination, as per the study qualification evaluation.
The Schedule of Study Activities that outlines all of the subject activities from study entry to completion is contained in Appendix E.
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